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NCT06357442 · ClinicalTrials.gov registry record
Assessment of Endometrial Thickness Among Adolescent and Young Adult Patients on Estrogen Replacement Therapy Using Daily Oral Micronized Progesterone Versus the Etonogestrel Implant.
A clinical trial of Hypogonadotropic Hypogonadism and Primary Ovarian Insufficiency, sponsored by University of Colorado, Denver.
- Recruiting
- Registry status
- 34
- Enrollment target
- 1
- Study location
NCT06357442 is a study of Hypogonadotropic Hypogonadism and Primary Ovarian Insufficiency that is actively recruiting participants, run by University of Colorado, Denver. The registered enrollment target is 34 participants, below the 121-participant average among 6 other Hypogonadotropic Hypogonadism trials with a reported enrollment target (72% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06357442, a study of Hypogonadotropic Hypogonadism and Primary Ovarian Insufficiency, is actively recruiting participants, sponsored by University of Colorado, Denver.
- RECRUITING
- Registry status
- 34 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this observational study is to compare endometrial stripe thickness in adolescent and young adult (AYA) patients with a uterus on estrogen replacement therapy using oral progesterone versus the etonogstrel implant for endometrial protection. The main questions it aims to answer are: Aim 1: Characterize the mean endometrial thickness in AYA on estrogen hormone replacement therapy before initiation of progesterone therapy Aim 2: Characterize the mean changes and variability in endometrial thickness in AYA treated for 6 months with either the etonogestrel implant or continuous oral progesterone Aim 3: Assess satisfaction, side effects, bleeding patterns, any progesterone modifications, and adherence in AYA treated for 6 months with either etonogestrel implant or continuous progesterone Participants will be asked to: * Get two pelvic ultrasounds * Fill out two surveys * Continue their current hormone replacement therapy * Initiate one of two progesterone therapies (prometrium 100mg daily or Nexplanon) Researchers will compare the change in endometrial thickness after 6 months of progesterone use to see if there is a significant difference in the mean change between the prometrium and Nexplanon groups.
Conditions Studied
Study Locations (1)
Colorado
- Childrens Hospital Colorado - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2024-07-01 |
| Est. Completion | 2026-07-01 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06357442
The ClinicalTrials.gov registry entry for NCT06357442 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 121-participant average among 6 other Hypogonadotropic Hypogonadism trials with a reported enrollment target (72% lower). The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Hypogonadotropic Hypogonadism appearing as the primary indexed condition, and to 0 interventions.
NCT06357442 reports 1 study location spanning 1 distinct geographic area - top geographies include Colorado.
Frequently Asked Questions
What is clinical trial NCT06357442 about?
NCT06357442 is a clinical study titled "Assessment of Endometrial Thickness Among Adolescent and Young Adult Patients on Estrogen Replacement Therapy Using Daily Oral Micronized Progesterone Versus the Etonogestrel Implant.". The goal of this observational study is to compare endometrial stripe thickness in adolescent and young adult (AYA) patients with a uterus on estrogen replacement therapy using oral progesterone versus the etonogstrel implant for endometrial protection. The main questions it aims to answer are: Ai...
What is the current status of trial NCT06357442?
This trial is currently recruiting. The enrollment target is 34 participants. The study started on 2024-07-01. Estimated completion is 2026-07-01.
What conditions does trial NCT06357442 study?
This clinical trial studies the following conditions: Hypogonadotropic Hypogonadism, Primary Ovarian Insufficiency, Hormone Replacement Therapy.
Who is sponsoring clinical trial NCT06357442?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06357442 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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